Contact information
Type
Scientific
Primary contact
Ms Sue Macdonald
ORCID ID
Contact details
15 Mansfield Street
London
W1G 9NH
United Kingdom
+44 (0)207 312 3468
Sue.Macdonald@rcm.org.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
07/MRE12/2
Study information
Scientific title
Acronym
PEARLS
Study hypothesis
That the provision of an evidence based training package and its delivery to practitioners will lead to better outcomes for women following perineal trauma.
Ethics approval
Thames Valley Research Ethics Committee, University of Reading. Approved in February 2007.
Study design
Randomised controlled trial using a matched pair cluster design. Maternity units are the unit of randomisation.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details provided in the Interventions field to request a patient information sheet.
Condition
Perineal trauma
Intervention
A paired cluster design trial investigating the intervention of an evidence based, standardised training package delivered to midwives and obstetricians, in the assessment and management of perineal trauma. Twenty-four maternity units have been recruited and matched into 12 pairs. The training intervention will initially commence in one unit in each 'pair' (Group A) with it's matched partner continuing to provide usual care (Group B).
All women in participating units will receive written information antenatally, at around 36 weeks. Following birth, further information about the study will be provided, and informed consent obtained on the Labour Ward, or prior to discharge. Women who participate will receive a pack to take home including a covering letter, 10-12 day questionnaire and a Self Addressed Envelope (SAE). Following receipt of the first questionnaire, the second questionnaire will be sent with an SAE at 3 months.
Main study outcomes will be assessed at three months following cascading of the intervention in Group A units. The intervention will then be cascaded among Group B units.
Please use the following contact details to request a patient information sheet:
Sue Tohill/ Linda Lucking
PEARLS Central Office
Academic Unit of Obstetrics & Gynaecology
University Hospital of North Staffordshire
Newcastle Road
Stoke on Trent, ST4 6QG, UK
Linda Lucking:
Tel: +44 (0)1782 552484; Fax: +44 (0)1782 552472; Email: Linda.Lucking@uhns.nhs.uk
Sue Tohill:
Tel: +44 (0)7880 942330; Email: sue.tohill@rcm-pearls.org
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
21/03/2013: The previous primary outcome measures were incorrect due to an error at the time of registration. The correct primary outcome measure is as follows:
Experience of perineal pain on daily activity at 10-12 days post birth.
Previous primary outcome measures until 21/03/2013:
Women's perspectives on what they consider important in the quality and experience of their care:
1. Infection and antibiotic treatment
2. Pain
3. Healing
4. Continence
Secondary outcome measures
21/03/2013: The previous secondary outcome measures were incorrect due to an error at the time of registration. The correct secondary outcome measures are as follows:
1. 10 - 12 days post birth:
1.1. severity of perineal pain
1.2. need for suture removal
1.3. use of pain relief duirng the previous 24 hours
1.4. uptake and duration of exclusive breastfeeding
1.5. perineal wound infection
2. Three months post birth:
2.1. Edinburgh Postnatal Depression Scale (EPDS [14])
score of ≥ 13
2.2 timing of resumption of intercourse
2.3. satisfaction with the perineal repair.
2.4. duration of exclusive breastfeeding
Previous secondary outcome measures until 21/03/2013:
1. Maternal physical and psychological well-being, assessed by the 10 day and 3 month questionnaires:
1.1. Incidence of perineal pain
1.2. Use of postpartum analgesia
1.3. Perineal wound infection
1.4. Uptake and duration of breastfeeding
2. Proportion of women who have an Edinburgh Postnatal Depression Scale (EPDS) score of greater than or equal to 13 at 3 months.
Overall trial start date
01/12/2005
Overall trial end date
01/02/2009
Reason abandoned
Eligibility
Participant inclusion criteria
All women who sustain a second degree perineal tear or episiotomy in a participating unit during the study period will be eligible. To avoid problems with selection biases, overall outcomes for the centre will be ascertained using audit data from birth records. All births during a prespecified period will contribute to these analyses.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
1,000
Participant exclusion criteria
1. Women under 16 years of age
2. Non-English speakers
3. Those who have suffered pregnancy loss
Recruitment start date
01/12/2005
Recruitment end date
01/02/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
15 Mansfield Street
London
W1G 9NH
United Kingdom
Sponsor information
Organisation
Royal College of Midwives (UK)
Sponsor details
c/o Mrs Louise Silverton
Deputy General Secretary
15 Mansfield Street
London
W1G 9NH
United Kingdom
+44 (0)207 312 3535
louise.silverton@rcm.org.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Health Foundation - Quality Improvement Initiative (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/20184764
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24059602
Publication citations
-
Protocol
Bick DE, Kettle C, Macdonald S, Thomas PW, Hills RK, Ismail KM, PErineal Assessment and Repair Longitudinal Study (PEARLS): protocol for a matched pair cluster trial., BMC Pregnancy Childbirth, 2010, 10, 10, doi: 10.1186/1471-2393-10-10.
-
Results
Ismail KM, Kettle C, Macdonald SE, Tohill S, Thomas PW, Bick D, Perineal Assessment and Repair Longitudinal Study (PEARLS): a matched-pair cluster randomized trial., BMC Med, 2013, 11, 209, doi: 10.1186/1741-7015-11-209.